Cluster Lead, Pharmacovigilance, LATAM

ModernaTX, Inc. seeks a Cluster Lead, Pharmacovigilance, LATAM for its Cambridge, Massachusetts location.   Here’s What You’ll Do: Responsible for end-to-end oversight of pharmacovigilance (PV) operations across multiple Latin American countries, including the implementation and continuous improvement of PV systems to ensure compliance with local and international regulatory requirements. Provide dynamic leadership and strategic oversight of PV operations in Latin America, ensuring excellence in execution, and define the PV strategy for the region and develop actionable short-, medium-, and long-term plans to achieve safety and compliance goals. Engaging with local Health Authorities to understand, interpret, and align Moderna’s safety reporting processes with country-specific legislation, particularly in a region where regulatory frameworks are actively evolving. Establish governance and operational processes with business partners and vendors, including the development of safety data exchange agreements and procedures for case processing, reconciliation, and audit preparedness. Regularly coordinate with global teams to ensure the exchange of safety information meets internal standards and regulatory expectations. Develop and review Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs/PBRERs), and local literature screening strategies. Collaborate with cross-functional internal teams such as Regulatory Affairs, Commercial, and Clinical Development to ensure PV is embedded throughout the product lifecycle. Deliver cross-divisional projects that strengthen collaboration with global teams and support corporate safety objectives. Ensure full regional compliance with PV reporting requirements and regulatory expectations. Lead PV inspection readiness efforts and participate in internal audits and external inspections by partners and health authorities. Maintain and continuously improve a robust PV Quality Management System and Business Continuity Plan. Oversee the performance and compliance of vendors and partners executing PV activities on behalf of Moderna across the region. Engage with external stakeholders to benchmark and implement best practices in pharmacovigilance. Participate in regional safety vendor qualification, internal and external audits, and quality management activities to uphold safety and compliance standards. Here’s What You’ll Bring to the Table:

Requires a Master’s degree or foreign equivalent in Pharmaceutical Sciences or a related field and 8 years of experience as a Pharmacovigilance Lead, Senior Pharmacovigilance/Drug Safety Specialist, or related position supporting pharmacovigilance operations. Alternatively, employer will accept a Bachelor’s degree, or foreign equivalent, in the fields specified and 10 years of specified progressive, post-baccalaureate experience. 8 years of experience must include: Pharmacovigilance oversight and regulatory engagement for the LATAM region applying Good Pharmacovigilance Practices for the Americas and local PV regulations for Mexico, Argentina, Brazil, Paraguay, Colombia, Panama, Peru and Chile; Individual Case Safety Report (ICSR) processing, aggregate safety reporting, Pharmacovigilance Quality Management Systems, and compliance; Ensuring timely and accurate safety data management, maintaining robust quality systems, and aligning regional LATAM pharmacovigilance operations with global regulatory standards; Working with Contract Research Organizations (CROs), vendors, business partners and stakeholders across cross-functional teams to ensure aligned pharmacovigilance operations; Veeva Safety and Argus; Risk Management Plans (RMP), Periodic Safety Updated Reports (PSUR), and development of Standard Operating Procedures (SOPs) and Pharmacovigilance Agreements (PVA); and Pharmacovigilance Management for business partners and vendors. Position requires up to 15% domestic and international travel, fully